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SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

Primary Purpose

Acute Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SmartCare/PS-NIV Drägerwerk Lübeck Germany
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Non invasive ventilation, Computer-driven system, Acute respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute respiratory failure requiring non invasive ventilation
  • ICU patient equipped with an arterial line.

Exclusion Criteria:

  • Contra-indications to NIV:
  • impaired consciousness
  • absence of patient cooperation
  • severe hemodynamic instability
  • vomiting
  • facial lesions
  • indication for immediate intubation
  • Acute neurological problem
  • Poor short term prognosis

Sites / Locations

  • Adult Intensive Care and Burn unit, University Hospital of Lausanne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Outcomes

Primary Outcome Measures

Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings.

Secondary Outcome Measures

Respiratory rate
Minute ventilation
Tidal volumes
Leaks
O2 saturation
Transcutaneous measurement
Alarms generated by the ventilator
Manual ventilator settings modifications required
Patient-ventilator asynchronies
Blood gas analysis
Two blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment.
Patient comfort
Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.
Percentage of time spent in a predifined comfort zone.
The comfort zone will be defined as respiratory rate between 14 and 29 breaths/minunte and tidal volume between 5 and 10 ml/ kg IBW
Heart rate
Blood pressure

Full Information

First Posted
May 23, 2013
Last Updated
May 3, 2017
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01870089
Brief Title
SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study
Official Title
Clinical Evaluation of an Automated Knowledge-based Computer Driven System (SmartCare/PS-NIV) Designed to Automatically Adapt Pressure Support Level and Expiratory Cycling During Non Invasive Ventilation, a Feasability Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Enough data to conclude
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians. Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality. NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment. A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction. The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Non invasive ventilation, Computer-driven system, Acute respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SmartCare/PS-NIV Drägerwerk Lübeck Germany
Primary Outcome Measure Information:
Title
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
Description
The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings.
Time Frame
45 minute NIV-treatment
Secondary Outcome Measure Information:
Title
Respiratory rate
Time Frame
45 minutes
Title
Minute ventilation
Time Frame
45 minutes
Title
Tidal volumes
Time Frame
45 minutes
Title
Leaks
Time Frame
45 minutes
Title
O2 saturation
Description
Transcutaneous measurement
Time Frame
45 minutes
Title
Alarms generated by the ventilator
Time Frame
45 minutes
Title
Manual ventilator settings modifications required
Time Frame
45 minutes
Title
Patient-ventilator asynchronies
Time Frame
45 minutes
Title
Blood gas analysis
Description
Two blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment.
Time Frame
45 minutes
Title
Patient comfort
Description
Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.
Time Frame
45 minutes
Title
Percentage of time spent in a predifined comfort zone.
Description
The comfort zone will be defined as respiratory rate between 14 and 29 breaths/minunte and tidal volume between 5 and 10 ml/ kg IBW
Time Frame
45 minutes
Title
Heart rate
Time Frame
45 minutes
Title
Blood pressure
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute respiratory failure requiring non invasive ventilation ICU patient equipped with an arterial line. Exclusion Criteria: Contra-indications to NIV: impaired consciousness absence of patient cooperation severe hemodynamic instability vomiting facial lesions indication for immediate intubation Acute neurological problem Poor short term prognosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Jolliet, Prof
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adult Intensive Care and Burn unit, University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

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